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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000017086
Receipt No. R000019794
Scientific Title Effects of cognitive behavioral therapy in prosthodontic treatment:randomized controlled trial(RCT)
Date of disclosure of the study information 2015/04/10
Last modified on 2017/03/09

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Basic information
Public title Effects of cognitive behavioral therapy in prosthodontic treatment:randomized controlled trial(RCT)
Acronym Effects of cognitive behavioral therapy in prosthodontic treatment
Scientific Title Effects of cognitive behavioral therapy in prosthodontic treatment:randomized controlled trial(RCT)
Scientific Title:Acronym Effects of cognitive behavioral therapy in prosthodontic treatment
Region
Japan

Condition
Condition free-end missing teeth in molar region
Classification by specialty
Dental medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 comparison of improvement
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes improvement in subjective evaluations before and after the treatment
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Double blind -all involved are blinded
Control No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Educational,Counseling,Training
Type of intervention
Behavior,custom
Interventions/Control_1 interventions:cognitive behavioral therapy
Interventions/Control_2 control:providing explanations about treatment
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
20 years-old <=
Age-upper limit
100 years-old >=
Gender Male and Female
Key inclusion criteria .subjects who have free end missing teeth in molar region in one or both sides,and receive prosthodontic treatment with a removable partial denture
.subjects who don't wear a removable partial denture or have missing teeth in opposing dental arch that require prosthodontic treatment
Key exclusion criteria .subjects suffering serious mental illness
.subjects who cannot fill out a questionnaire for disorientation
.pregnant and breast-feeding women,and women planning to get pregnant during this study
Target sample size 40

Research contact person
Last name of lead principal investigator
1st name
Middle name
Last name Kiyoshi Koyano
Organization Fuclty of Dental Science,Kyushu university
Division name Section of Implant and Rehabilitative Dentistry Devision of Rehabilitation
Zip code
Address 3-1-1,maidashi,higashi-ku,fukuoka-shi,fukuoka-ken
TEL 092-642-6441
Email n-tsuji@dent.kyushu-u.ac.jp

Public contact
1st name of contact person
1st name
Middle name
Last name Nozomi Tsuji
Organization Faculty of Dental Science,Kyushu university
Division name Section of Implant and Rehabilitative Dentistry Devision of Rehabilitation
Zip code
Address 3-1-1,maidashi,higashi-ku,fukuoka-shi,fukuoka-ken
TEL 092-642-6441
Homepage URL
Email n-tsuji@dent.kyushu-u.ac.jp

Sponsor
Institute Section of Implant and Rehabilitative Dentistry Devision of Rehabilitation
Faculty of Dental Science,Kyushu university
Institute
Department

Funding Source
Organization Ministry of Education, Culture, Sports, Science and Technology
Organization
Division
Category of Funding Organization Japanese Governmental office
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information
2015 Year 04 Month 10 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Completed
Date of protocol fixation
2015 Year 03 Month 27 Day
Date of IRB
Anticipated trial start date
2015 Year 04 Month 15 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2015 Year 04 Month 09 Day
Last modified on
2017 Year 03 Month 09 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019794

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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